White Paper

Risk-Based Monitoring - Can You Afford To Wait?

On-site monitoring is one of the largest cost drivers in a trial, accounting for 30 percent on average of the cost of a clinical trial. Fifty percent of the cost of on-site monitoring involves ensuring data quality through source document verification (SDV). In a time when the pressure is on clinical operations to lower development costs and improve outcomes, the life science industry spent $7.5 billion in 2014 on SDV.1,5 Nevertheless, industry and regulatory leaders still express concern that traditional monitoring does not sufficiently evaluate the quality of study data. While significant resources are spent to verify that the source data matches the captured data, traditional monitoring processes often fail to focus on the bigger issues of data quality and protocol violations.